Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

Hypertension Clinical Trial

— TAHPS  

Official title:

Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741922
• Other study ID #: TAHPS-2011-004760-29
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2012
• Last updated: February 2, 2017
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to investigate in patients with high blood pressure, BP, namely, those with systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90 mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA, whether changing the time they take the drug (same dose) to bedtime (from taking it at some point during the active part of the day) produces a drop in their blood pressure (mean systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in their night BP when the drug is taken in the evening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Hypertensive patients (=140/90)

• Patients from 18 to 80 years old

• Patients are currently taking low doses of ASA during the day, for secondary prevention of cardiovascular events

• Patients have been stable for at least one month with their current antihypertensive and antiplatelet therapy.

Exclusion Criteria:

• Severe and/or terminal illness

• Moderate/severe congestive heart failure (CHF), New York Heart Association, NYHA stage = III

• Moderate/severe chronic renal failure glomerular filtration rate <45ml/min.

• Physical or mental illness that prevents the patient´s collaboration

• Being a heavy drinker, consuming more than 280 g of alcohol per week in the case of men or 170 g for women31

• Concomitant treatment with other antiplatelets or anticoagulants

• Taking nonsteroidal antiinflammatory drugs, NSAIDs, on a regular basis

• Treatment with ASA at doses outside those established in the inclusion criteria (above)

• ASA already being taken in the evening

• Being a shift worker or having a very intensive work schedule

• Hospital admission during the clinical trial

• Changes being made in the antihypertensive and antiplatelet therapy taken by the patient during the seven months of the trial

• Patients with unstable treatment or clinical condition requiring frequent adjustments thereof.

• Compliance with less than 90% of the doses, both those for daytime and those for evening administration

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• ASA evening
Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups
• Acetylsalicylic morning
Patients will be assigned in a blind and randomized way to one of two parallel groups: group I with the control treatment during the first two months, namely, administration of aspirin 100 mg, in the morning and placebo in the evening and group II initially receiving the intervention, of administration of aspirin 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups, i.e., patients randomly allocated to group I, so having taken aspirin in the morning and placebo in the evening, will now receive the intervention treatment, namely, administration of ASA in the evening and placebo in the morning for another two months and vice verse.
• Placebos morning
Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups
• Placebo evening
Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

Locations

Country	Name	City	State
Spain	Primary care of IDIAP Jordi Gol	Barcelona	Catalonia
Spain	Primary Care Research Unit of Bizkaia	Bilbao	Bizkaia
Spain	Primary Care Research Unit of Bizkaia	Gipuzkoa Oeste	Gipuzkoa

Sponsors (4)

Lead Sponsor	Collaborator
Basque Health Service	Preventive Services and Health Promotion Research Network, Public Health Service of Cataluña, Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ruíz-Arzalluz MV, Fernández MC, Burgos-Alonso N, Vinyoles E, San Vicente Blanco R, Grandes G; TAHPS group.. Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial. Trials. 2013 Jul 27;14:236. doi: 10.1186/1745-6215-14-236. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period	To evaluate the effect of evening administration of low doses of aspirin (100 mg) on the BP of hypertensive patients with high cardiovascular risk, comparing with the effect of day administration, we are going to measure the change in the mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period from baseline at the end of the study, five months later.	Change from baseline in sistolyc blood pressure at five months
Secondary	Mean of day/night SBP and DBP ratios measured with Ambulatory Blood Pressure monitoring Monitoring	To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention. We are going to describe the changes in day-night pattern of BP as a function of the time of administration of low doses of aspirin in non-dipper patients, objectified by the mean of day:night SBP and DBP ratios.	Change from baseline in sistolyc blood pressure at five months
Secondary	The mean of heart rate (HR) and the mean of pulse pressure (PP)	To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention. We are going to identify any changes in the mean of heart rate (HR) and the mean of pulse pressure (PP) with evening administration of ASA.	Change from baseline in sistolyc blood pressure at five months
Secondary	Percentage of adverse events related to ASA evening administration versus day administration	we are going to measured the percentage of adverse events at the end of the study to assess any changes in the side effects of aspirin when it is taken in the evening compared to day-time administration.	Change from baseline in sistolyc blood pressure at five months